Donatine

Package Leaflet: Information for the Patient

Donatine, 5 mg, coated tablets

Donatine, 10 mg, coated tablets

Donepezil hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Donatine and what is it used for
• 2. Important information before taking Donatine
• 3. How to take Donatine
• 4. Possible side effects
• 5. How to store Donatine
• 6. Contents of the pack and other information

1. What is Donatine and what is it used for

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.
It is used to treat the symptoms of mild to moderate Alzheimer's disease.
The symptoms include increasing memory loss, disorientation, and changes in behavior.
As a result, people with Alzheimer's disease have increasing difficulty performing their daily activities.
Donepezil is intended for use in adults only.

2. Important information before taking Donatine

When not to take Donatine

• If you are allergic to donepezil hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• 6.

Warnings and precautions

Before taking Donatine, tell your doctor or pharmacist if you have or have had:

• stomach or duodenal ulcer,
• seizures or convulsions,
• heart problems (such as irregular or very slow heart rate, heart failure, heart attack),
• a heart condition called "prolonged QT interval" or have had certain heart rhythm problems called torsade de pointes or have had "prolonged QT interval" in the past,
• low magnesium or potassium levels in the blood
• asthma or other chronic lung disease,
• liver problems or hepatitis,
• difficulty urinating or mild kidney problems.

You should also tell your doctor if you are pregnant or think you may be pregnant.

Children and adolescents

Donatine is not recommended for use in children and adolescents (under 18 years).

Donatine with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
It is particularly important to tell your doctor if you are taking any of the following medicines:

• medicines used to treat heart rhythm problems, such as amiodarone, sotalol;
• medicines used to treat depression, such as citalopram, escitalopram, amitriptyline, fluoxetine;
• antipsychotic medicines, such as pimozide, sertindole, ziprasidone;
• medicines used to treat bacterial infections, such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin;
• antifungal medicines, such as ketoconazole;
• other medicines used to treat Alzheimer's disease, such as galantamine, painkillers or medicines used to treat arthritis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs, such as ibuprofen or diclofenac
• anticholinergic medicines, such as tolterodine
• antiepileptic medicines, such as phenytoin, carbamazepine
• medicines used to treat heart problems, such as quinidine, beta-blockers (propranolol and atenolol)
• muscle relaxants, such as diazepam, succinylcholine
• medicines used for general anesthesia
• over-the-counter medicines, such as herbal preparations

If you are scheduled to have surgery that requires general anesthesia, you should inform your doctor and anesthesiologist that you are taking Donatine. This medicine may affect the amount of anesthetic needed.
Donatine can be used in patients with kidney or mild to moderate liver problems. You should tell your doctor if you have kidney or liver problems.
Patient with severe liver problems should not take Donatine.
You should give your doctor or pharmacist the name of your caregiver. The caregiver will help you take the medicine as directed by your doctor.

Donatine with food, drink, and alcohol

Food does not affect the absorption of Donatine.
You should not drink alcohol while taking Donatine, as alcohol may affect the action of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women taking Donatine should not breastfeed.

Driving and using machines

Alzheimer's disease may impair your ability to drive or operate machines; therefore, you should not perform these activities until your doctor has confirmed that it is safe to do so.
The medicine may cause fatigue, dizziness, and muscle cramps. If these symptoms occur, you should not drive or operate machines.

Donatine contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Donatine.

3. How to take Donatine

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Treatment usually starts with 5 mg (one white tablet) once daily, in the evening before bedtime.
After one month, your doctor may increase the dose to 10 mg (one yellow tablet) once daily, in the evening before bedtime.
If you experience unusual dreams, nightmares, or difficulty sleeping (see section 4), your doctor may recommend taking Donatine in the morning.
Take Donatine before bedtime, with a glass of water.
The dose of the tablet may be changed depending on the duration of treatment and your doctor's recommendations. The maximum recommended dose is 10 mg once daily, in the evening before bedtime.
Always follow the instructions of your doctor or pharmacist regarding how and when to take the medicine. Do not change the dose of the medicine yourself.

How long to take Donatine

Your doctor will tell you how long to continue taking the tablets. From time to time, you should consult your doctor to reassess your symptoms and the course of treatment.

Taking more Donatine than prescribed

If you take more Donatine than you should, contact your doctor or go to the nearest hospital immediately. Always take the tablets and the package of the medicine with you, so that the doctor knows what has been taken.
Overdose symptoms may include: nausea (vomiting), vomiting, salivation, sweating, slow heart rate, low blood pressure (feeling of emptiness in the head or dizziness when standing up), breathing difficulties, collapse, and seizures or convulsions.

Missing a dose of Donatine

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you have missed taking Donatine for more than a week, consult your doctor before restarting treatment.

Stopping Donatine treatment

Do not stop taking Donatine unless your doctor tells you to do so. After stopping treatment with Donatine, the beneficial effects of the treatment will gradually decrease.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Donatine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Donatine.

If you experience any of the following side effects, contact your doctor.

Severe side effects:

Tell your doctor immediately if you experience any of the following side effects. You may need urgent medical attention.

• stomach or duodenal ulcers. Symptoms of stomach ulcers are stomach pain and discomfort (indigestion) felt in the area between the navel and the breastbone (symptoms may occur in less than 1 in 100 people).
• bleeding from the stomach or intestines. This may cause black, tarry stools or visible blood in the stool (symptoms may occur in less than 1 in 100 people).
• seizures or convulsions (symptoms may occur in less than 1 in 100 people).
• liver damage, such as hepatitis. Symptoms of hepatitis include nausea or vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark urine (symptoms may occur in less than 1 in 1000 people).
• fever with muscle stiffness, sweating, or decreased consciousness (a condition called neuroleptic malignant syndrome) (symptoms may occur in less than 1 in 1000 people).
• muscle weakness, tenderness, or pain, especially if you feel unwell, have a fever, and dark urine. These may be symptoms of a condition called rhabdomyolysis, which can lead to kidney problems (symptoms may occur in less than 1 in 10000 people)
• fast, irregular heartbeat, fainting, which may be symptoms of a heart condition called torsade de pointes, which can be life-threatening (frequency cannot be estimated from the available data).

Other side effects

Very common: occur in more than 1 in 10 people:

• diarrhea
• nausea and vomiting
• headache

Common: occur in less than 1 in 10 people:

• muscle cramps
• fatigue
• insomnia (difficulty sleeping)
• colds
• loss of appetite
• hallucinations (seeing or hearing things that do not exist)
• unusual dreams (including nightmares)
• agitation
• aggressive behavior
• fainting
• dizziness
• indigestion
• vomiting
• rash
• itching
• incontinence
• pain
• accidents (patients may be more prone to falls and accidental injuries)

Uncommon: occur in less than 1 in 100 people:

• slow heart rate
• excessive salivation
• mild increase in muscle enzyme levels in the blood

Rare: occur in less than 1 in 1000 people:

• stiffness or uncontrolled movements of the muscles, especially of the face and tongue, but also of the limbs
• heart rhythm problems

Frequency not known (cannot be estimated from the available data):

• changes in heart function visible on an ECG called "prolonged QT interval";
• increased libido, hypersexuality
• Tower of Pisa syndrome (a condition characterized by involuntary muscle contraction with abnormal twisting of the body and head to one side).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Donatine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after (EXP). The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Donatine contains

The active substance of Donatine is donepezil hydrochloride. Each coated tablet contains donepezil hydrochloride monohydrate equivalent to 5 mg / 10 mg of donepezil hydrochloride.
The other ingredients are:
Tablet core:lactose monohydrate, maize starch, microcrystalline cellulose, hypromellose, magnesium stearate.

Coating:

For 5 mg tablets: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b)
For 10 mg tablets: Hypromellose (E464), titanium dioxide (E171), macrogol 400, talc (E553b), yellow iron oxide (E172).

What Donatine looks like and contents of the pack

Donatine is available as 5 mg and 10 mg tablets.
5 mg coated tablets: are white or almost white, round with a diameter of about 7.14 mm, biconvex with beveled edges and engraved with "5" on one side and smooth on the other side.
10 mg coated tablets: are yellow, round with a diameter of about 8.73 mm, biconvex with beveled edges and engraved with "10" on one side and smooth on the other side.
Donatine tablets are available in cardboard boxes in blisters of PVC/Aluminum in packs of 7, 10, 28, 30, 50, 56, 60, 84, 98, and 120 tablets or in HDPE bottles containing 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański

Importer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:November 2023